Toxo IgG/IgM cassette is intended to be used as a screening test of infection with T. gondii. Any reactive specimen with the Toxo IgG/IgM must be confirmed with alternative testing method(s) and clinical findings.
Toxo IgG/IgM cassette is a lateral flow chromatographic immunoassay.
The test cassette consists of 1) a burgundy colored conjugate pad containing recombinant T. gondii antigens conjugated with colloidal gold (T. gondii conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing two test bands (M and G bands) and a control band (C band). The M band is pre-coated with monoclonal anti-human IgM for detection of IgM anti-T. gondii antibody, G band is pre-coated with reagents for detection of IgG anti-T.gondii antibody, and the C band is pre-coated with a control line antibody.
Leptospirosis occurs worldwide and is a common mild to severe health problem for humans and animals, particularly in area with a hot and humid climate. The natural reservoirs for leptospirosis are rodents as well as a large variety of domesticated mammals. Human infection is caused by Leptospira interrogans, the pathogenic member of the genus of Leprospira1,2. The infection is spread via urine from the host animal.
After infection, leptospires are present in the blood until they are cleared after 4 to 7 days following the production of antiLeptospira interrogans antibodies, initially of the IgM class. Culture of the blood, urine and cerebrospinal fluid is an effective means of confirming the diagnosis during 1st to 2nd weeks after exposure. Serological detection of anti- Leptospira interrogans antibodies is also a common diagnostic method. Tests are available under this category:1) The microscopic agglutination test (MAT) ; 2) ELISA; 3) Indirect fluorescent antibody tests (IFATs).
The Leptospira IgG/IgM (Whole Blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of IgG and IgM antibodies to Leptospira in whole blood, serum or plasma. The membrane is precoated with recombinant HCV antigen on the test line region of the cassette. During testing, the whole blood, serum or plasma specimen reacts with recombinant Leptospira interrogans antigen conjugated colloid gold. The mixture migrates upward on the membrane chromatographically by capillary action to react with mouse anti-human IgG or/and mouse anti-human IgM on the membrane and generate a colored line.
Presence of this colored line indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.